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FDA 510(k)

SEALEX EXTRA ROOT CANAL SEALER

K-Number: K962885 · 1996-08-30

ApplicantBaladent
Decision Date1996-08-30
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEALEX EXTRA ROOT CANAL SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Baladent. It received FDA 510(k) clearance on 1996-08-30 under 510(k) number K962885. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEALEX EXTRA ROOT CANAL SEALER?

SEALEX EXTRA ROOT CANAL SEALER is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Baladent. The 510(k) number is K962885.

When did SEALEX EXTRA ROOT CANAL SEALER receive FDA 510(k) clearance?

SEALEX EXTRA ROOT CANAL SEALER received FDA 510(k) clearance on 1996-08-30, under 510(k) number K962885.

Who is the listed applicant for SEALEX EXTRA ROOT CANAL SEALER?

The FDA 510(k) record lists Baladent as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEALEX EXTRA ROOT CANAL SEALER?

The FDA product code for SEALEX EXTRA ROOT CANAL SEALER is KIF.

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Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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